Sun Pharmaceutical Industries on Monday announced the availability of Winlevi cream, used for the treatment of acne vulgaris in patients 12 years and older, in the US market.
A first-in-class topical androgen receptor inhibitor, Winlevi was approved by the US Food and Drug Administration (FDA) in August 2020.
Winlevi is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years, Sun Pharma said in a statement.
It works by inhibiting the effects of androgen receptors in cells of the sebaceous glands (oil producing glands in the skin) to help reduce sebum (oil) production and inflammation.
It is suitable for both males and females.
"The US launch of WINLEVI enhances Sun Pharma’s specialty product portfolio and reflects our commitment to meeting patients’ needs by providing innovative dermatology medicines,” Sun Pharma CEO (North America) Abhay Gandhi said.
With its safety and tolerability profile, combined with its demonstrated efficacy in clinical trials, Winlevi has the potential to be an important topical treatment option for the millions of Americans affected by acne vulgaris, he added.
The most prevalent skin condition in the US, acne affects up to 50 million Americans annually, the company said citing data.
Prior to the availability of Winlevi, conventional topical approaches to acne treatment focused on either addressing follicular hyperkeratinisation, reducing inflammation, or exerting antibacterial effects.
In August this year, Sun Pharma and specialty pharma firm Cassiopea SpA had inked an exclusive licence and supply agreements for Winlevi cream.
As per the pact, Sun Pharma has the exclusive right to commercialise Winlevi in the US and Canada.
Cassiopea is the exclusive supplier of the product.
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